PUBLIC DESCRIPTION Akston is developing a subcutaneously administered therapeutic for preventing or delaying the onset of diabetes in pre-diabetic patients who are at high risk (those who display autoantibodies for insulin, GAD65, IA-2, and ZnT8) for developing Type 1 diabetes (T1D). The therapeutic is designed to delete a subset of B-cells that likely play a role in disease development using a patient?s own antibody directed cell cytotoxicity machinery. The work covered in this submission builds on Phase 1 SBIR results obtained from mouse models of T1D. Before entering into the IND stage, however, Akston seeks to develop a clinically-acceptable manufacturing process, evaluate safety in rodent and non-human primates, and confirm the therapeutic performance with human cells obtained from T1D patients. Doing so will provide a critical risk reduction to justify further IND-enabling safety and efficacy work, and, eventually, clinical testing of the therapeutic in man. The impacts to public health as a result of this project are potentially significant. Healthcare costs directly attributable to T1D patients currently account for nearly $15 billion annually. In addition to the 3 million Americans who currently live with T1D, 30,000 new T1D patients are diagnosed each year, with the rate of newly diagnosed patients < 20 years of age increasing by 23% in just the past decade. If successful, Akston?s therapeutic could lead to a significant reduction in health care costs and possibly free pre-T1D children and teenagers from a lifetime of glucose monitoring and insulin injections.